UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047936 |
|---|---|
| Receipt number | R000054637 |
| Scientific Title | A Clinical Trial on Antifatigue Effect: A Randomized, Placebo-Controlled, Double-Blind, Parallel-group Comparison Study |
| Date of disclosure of the study information | 2022/06/03 |
| Last modified on | 2023/02/06 15:35:48 |
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Basic information
Public title
A Clinical Trial on Antifatigue Effect
Acronym
A Clinical Trial on Antifatigue Effect
Scientific Title
A Clinical Trial on Antifatigue Effect: A Randomized, Placebo-Controlled, Double-Blind, Parallel-group Comparison Study
Scientific Title:Acronym
A Clinical Trial on Antifatigue Effect
Region
| Japan |
Condition
Condition
Healthy Japanese subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The main objective of this trial is to investigate the anti-fatigue effects of a 3-week, continuous daily consumption of red ginseng extracts on healthy Japanese adults.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The measured values of Visual Analogue Scale (VAS) scores at 3 weeks after the start of test-food consumption.
Key secondary outcomes
The measured values of plasma cortisol and lactate levels at 3 weeks after the start of test-food consumption.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Duration: 3 weeks
Test food: KRG-A
Administration: 2 capsules/day (Take 2 capsules with water at any time during the day)
* Daily dose should be taken within the day. If you forget to take the capsules, take them as soon as you remember during that day.
Interventions/Control_2
Duration: 3 weeks
Test food: KRG-B (placebo)
Administration: 2 capsules/day (Take 2 capsules with water at any time during the day)
* Daily dose should be taken within the day. If you forget to take the capsules, take them as soon as you remember during that day.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Japanese male and female
2. 40-60 years of age
3. Healthy individual
4. Subjects who feel fatigue daily
5. Within the subjects who met 1st to 4th inclusion criteria (1, 2, 3, 4), subjects whose VAS of fatigue are relatively high
Key exclusion criteria
1. Subjects undergoing medical treatment or having a medical history of malignant tumor, heart failure, or myocardial infarction
2. Subjects carrying a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Subjects undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage, including Ginseng products, as part of their daily intake
5. Subjects currently regularly taking medications (including herbal medicines) and supplements
6. Subjects allergic to medications and/or the test-food related products
7. Subjects who are pregnant, breast-feeding or planning for pregnancy
8. Subjects who are being infected with COVID-19
9. Subjects who have been enrolled in other clinical trials within 28 days before the agreement to participate in this trial or plan to enroll in another clinical trial during trial period
10. Subjects who are deemed ineligible to participate in the study by the principal investigator
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Takara |
Organization
Medical Corporation Seishinkai, Takara Clinic
Division name
Director
Zip code
141-0022
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
TEL
03-5793-3623
t-takara@takara-clinic.com
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Suzuki |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL
03-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
Funding Source
Organization
Kyung Hee University
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address
9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel
03-5793-3623
IRB@takara-clinic.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 06 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
46
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 05 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 02 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 06 | Month | 03 | Day |
Last modified on
| 2023 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054637
